NanoBio Influenza Mucosal Vaccine Program:

NanoBio has demonstrated protection and prophylaxis against influenza with

prototype mucosal vaccines in several studies partially represented below:

• Significant immune response demonstrated in ferrets: NanoBio has recently demonstrated the significant strength of its influenza vaccine in ferret studies. Because the mucosal vaccine triggers such robust immunity, NanoBio scientists anticipate they will be able to reduce vaccine antigen quantities to a fraction of what current vaccines require, while still mounting an overwhelming immune response. These data will be released in the spring of 2008.

• Protection after mucosal vaccination in mice: 100% survival has been demonstrated in several studies in which mice were exposed to highly lethal doses of several different influenza strains.

• Cross strain immunogenicity after vaccination against a single strain: Mice were vaccinated with the H2N2 strain, then challenged with a lethal dose of H2N2. 100% of these mice survived.  These same mice were then rechallenged with a lethal dose of a different strain, H1N1, again resulting in a 100% survival.

• Prophylaxis after application of an antigen free nanoemulsion to the nares:  An antigen free nanoemulsion was applied to the nares of mice, a lethal dose 80 influenza was then nebulized into chamber, eighty percent of animals pretreated with saline alone died from influenza pneumonia.  70% of the antigen free emulsion-treated animals survived the challenge. 

Many of the safety studies, the stability data and the manufacturing scale-up activities included in this program are supportive of the development of additional NanoStat platform based mucosal vaccines. 

About Influenza:

The currently circulating influenza viruses that cause human disease are defined by two different surface protein components know as antigens.  These antigens are spike-like structures called haemagglutinin (H) and neuraminidase (N).  The identity of influenza viruses is defined by these antigens.  Examples include: H1N1 and H5N1.

The virus is highly infectious and passed from person to person through the air by droplets and small particles excreted when infected individuals cough or sneeze.  The influenza virus enters the body through the nose or throat.  It then takes between one and four days for the person to develop symptoms.  Individuals suffering from influenza can be infectious from the day before they develop symptoms until seven days afterwards.

The influenza A viruses have undergone three major genetic changes, mainly in their H-component during the past century, resulting in global pandemics and large tolls in terms of both disease and deaths.  Most recently, limited outbreaks of a new influenza subtype A (H5N1) directly transmitted from birds to humans ("Bird Flu") have occurred in several regions of the world.